BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOUBLE TOOTHED GRASPER, 5 MM

    MDR report key: 28029 · Received November 10, 1995

    Report

    Report Number
    MW1007643
    Event Type
    Other
    Date Received
    November 10, 1995
    Date of Event
    November 10, 1995
    Report Date
    November 10, 1995
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC PROCEDURE, 5 MM DOUBLE TOOTHED GRASPER BROKE AT HINGED TIP. PIECE RETRIEVED FROM PT AND BIOMEDICAL ENGINEERING CONFIRMED THAT ALL PARTS WERE ACCOUNTED FOR. CONTACTED MFR. HAVE FORWARDED INSTRUMENT TO MFR FOR QUALITY ASSESSMENT. NO PRIOR HISTORY OF THIS INSTRUMENT HAVING PROBLEMS. PT HAS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE TOOTHED GRASPER, 5 MM DOUBLE TOOTHED GRASPER GEN RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8384.10

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other